Brief Title
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
Official Title
A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Brief Summary
A prospective, non-interventional, natural history study to assess the occurrence of higher
FNAIT risk across a broad population of different racial and ethnic characteristics and the
occurrence of HPA-1a alloimmunization in these women.
Study Type
Observational
Primary Outcome
Number of participants with higher FNAIT risk characterized by race and ethnicity
Secondary Outcome
Frequency of anti-HPA-1a maternal alloimmunization
Condition
Fetal and Neonatal Alloimmune Thrombocytopenia
Intervention
Clinical data collection
Study Arms / Comparison Groups
Pregnant women
Description: Women with higher risk of FNAIT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30000
Start Date
March 14, 2022
Completion Date
April 2024
Primary Completion Date
July 2023
Eligibility Criteria
Inclusion Criteria:
- Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
Exclusion Criteria:
- Participants with prior history of FNAIT
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, (203) 859-3820, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT05345561
Organization ID
IPA2002
Responsible Party
Sponsor
Study Sponsor
Rallybio IPA, LLC
Study Sponsor
, ,
Verification Date
August 2022